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Medical Devices / Submissions and Approvals

VitalConnect Extends Wear Duration of Wearable Biosensor

Dec. 12, 2017
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VitalConnect has secured its fifth 510(k) clearance for a 25 percent extension in the wear duration of its wearable sensor — the VitalPatch — from 96 hours to 120, or five days.

The company pointed to research from the HHS’ Agency for Healthcare Research and Quality that showed the national average for a patient’s hospital length of stay to be at 4.5 days, which makes the VitalPatch biosensor “ideally suited for hospital patient monitoring.”

The disposable biosensor is indicated for a single patient use, which can also be for post-discharge monitoring or remote patient monitoring. It is the “smallest and lightest wearable biosensor” for the continuous, real-time monitoring of eight biometric measurements, including single-lead electrocardiography, heart rate, and activity, the company said.

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